FDA product code ESZ: Tube, Shunt, Endolymphatic
ESZ is the FDA product code for tube, shunt, endolymphatic. It is a Class II device, regulated under 21 CFR 874.3820 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 4 510(k) submissions under ESZ, from 4 different applicants. The average 510(k) review took 124 days (median 83).
Classification
| Field | Value |
|---|---|
| Device name | Tube, Shunt, Endolymphatic |
| Device class | Class II |
| Regulation | 21 CFR 874.3820 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every ESZ clearance
Top ESZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Exmoor Plastics , Ltd. | 1 | 1998-01-27 |
| Trebay Medical Corp. | 1 | 1995-06-16 |
| Hood Laboratories | 1 | 1990-03-16 |
| Treace Medical, Inc. | 1 | 1984-09-20 |
Most recent ESZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K974224 | Exmoor Plastics , Ltd. | ENDOLYMPHATIC SAC TO MASTOID T-SHUNT | 1998-01-27 | 78 |
| K952227 | Trebay Medical Corp. | C-FLEX ENDOLYMPHATIC SHUNT | 1995-06-16 | 35 |
| K897049 | Hood Laboratories | GIBSON ENDOLYMPHATIC SHUNT | 1990-03-16 | 88 |
| K834094 | Treace Medical, Inc. | AUSTIN ENDOLYMPH DISPERSMENT SHUNT | 1984-09-20 | 297 |
Recalls for ESZ devices
openFDA lists no recalls for product code ESZ.
Frequently asked questions
What is FDA product code ESZ?
ESZ is the FDA product code for tube, shunt, endolymphatic. It is a Class II device, regulated under 21 CFR 874.3820 and reviewed by the Ear, Nose and Throat panel.
What device class is ESZ?
Class II, regulation 21 CFR 874.3820. Typical premarket route: 510(k).
How long does a 510(k) take for product code ESZ?
Across 4 cleared submissions the average was 124 days from receipt to decision (median 83).
Which companies have the most ESZ clearances?
Exmoor Plastics , Ltd. (1); Trebay Medical Corp. (1); Hood Laboratories (1); Treace Medical, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code ESZ
- Run a recall and safety report across every ESZ manufacturer
- Watch product code ESZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Ear, Nose and Throat product codes · FDA product code lookup · 510(k) database search · 510(k) review times